Quality Management System ISO13485

Important results from the project

The goal of the project was to develop and adjust the existing quality management system to also include hardware products. The following activities were successfully completed during the project: 1. Gap analysis of existing quality management system based on regulatory requirements specific to hardware 2. Adjustment of existing quality management system based on conclusions from gap analysis 3. Final alignment to ensure that the company acquired the internal competence required to ensure continued regularory compliance going forward.

Expected long term effects

The Competence Enforcement and the project has significantly increased the company´s internal competence for medical technology regulations and therefore also enabled future product launches within the company. The company´s hardware is currently undergoing clinical trials and the project team expects the quality management system to be certified (ISO13485) soon.

Approach and implementation

The project was carried out through analyzes based on medical regulations such as MDD and MDR, ISO 13485: 2016 and quality management systems of companies with similar size. Classification of the product was used to determine product-specific eligibility requirements of the quality management system and was later used to design product-specific processes. Through the project, the company has thereby strengthened internal competence for medical technology regulations and its associated work processes. This would not be possible without the support of Vinnova / Medtech4Health.